CLASS III ONGOING Drug recall · Reported 6 May 2026 · FDA Enforcement Report
Levocarnitine Injection, USP (200 mg/mL) Single-Dose Vial recalled
American Regent is recalling Levocarnitine Injection, USP (200 mg/mL) Single-Dose Vial, For intravenous use, distributed nationwide in the US. The recall was initiated on 16 Apr 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0494-2026
- FDA event ID
- 98787
- Recalling firm
- American Regent, New Albany, OH
- Brand
- Levocarnitine
- Manufacturer
- American Regent, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 16 Apr 2026
- FDA classified
- 28 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Apr 2026 | Recall initiated by company | |
| 28 Apr 2026 | Classified by FDA | +12 days |
| 6 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Missing Label
Product as listed by the FDA
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Levocarnitine Injection, USP (200 mg/mL) Single-Dose Vial, For intravenous use recalled?
Yes. American Regent recalled Levocarnitine Injection, USP (200 mg/mL) Single-Dose Vial, For intravenous use on 16 Apr 2026. The recall is Class III and its status is Ongoing. Recall number D-0494-2026.
Why was it recalled?
Labeling: Missing Label
Which lots are affected?
Lot 24159N0C0, Exp. June 30, 2026 Lot 25193N0C0, Exp. July 31, 2027
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Regent
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | ANNOUNCED | Epinephrine Injection, USP 30 mg/ (1 mg/mL) multi dose vial recalledAmerican Regent, Inc. | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Tralement (trace elements injection 4*, USP) recalled by American RegentTralement | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
Other Levocarnitine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levocarnitine Oral Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Levocarnitine Injection, Levocarnitine 500 MG/ML Injectable recalled | Fusion IV Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Levocarnitine Solution for injection, l-Carnitine 50 mg recalled | John W Hollis | Sterility | Nationwide |